The voice for pharmacy compounding │16 September 2022
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Compounders go to the Hill
Yesterday was an awesome day. Our voices were heard.
Thank you to everyone who joined us in Washington for APC’s Compounders on Capitol Hill. It was great to finally catch up after not being able to for so long. For those who couldn’t make it, you were missed!
On Wednesday, we hosted a very special guest: Gail Bormel, who is the Director, Office of Compounding Quality and Compliance at FDA. Scott Brunner interviewed Gail to gauge the agency’s views on a host of topics. Her insight was appreciated and helped give us clarity on the FDA’s positions.
The next day, our 140 attendees had over 160 visits scheduled with representatives and senators, and all but seven of these meetings were in-person. Over a few short hours on Thursday afternoon, we asked our Congresspeople to sign a letter to the FDA commissioner to avoid using the deeply flawed NASEM report to take action against compounded hormone replacement therapy. We also asked both members of Congress and the Senate to contact the FDA and ask for a delay in the implementation of GFI 256.
It wasn’t all work, though. We were able to raise funds for APC’s Pharmacy Compounding Foundation thanks to generous contributions by Fagron, Medisca, and PCCA. We had a fun evening watching the Washington Nationals play at Nationals Park against the Baltimore Orioles. It was great letting our hair down and having fun together as compounders and healthcare professionals.
If you weren’t able to join us in Washington this time, we hope you can make it in 2023. As soon as the Congressional calendar is released, we will begin working on next year's Compounders on Capitol Hill. I hope to see ALL of our members attend CCH next year. Can you imagine what we could get done if all 3,300 of us stormed the hill? It would be epic.
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David Miller is APC’s president and the managing co-owner of Keystone Compounding Pharmacy in Grand Rapids, Michigan. You can reach him at drdave@keystonepharm.com.
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ICYMI
Catch up on these recent stories that you might've missed:
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APC 2022 Fellows inducted | |
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On Wednesday, APC inducted 13 new members to its Fellows Program.
The APC Fellows Program was established in 1997 to distinguish those compounding professionals who are exemplary in their commitment and professionalism to the practice of pharmaceutical compounding.
Please join us in congratulating the 2022 APC Fellows:
- Melinda Browning, Civic Center Pharmacy, Scottsdale, Ariz.
- Jennifer Burch, Central Compounding Center, Durham, NC
- Stephanie Chacon, Empower Pharmacy, Houston, Tex.
- Tenille Davis, Civic Center Pharmacy, Scottsdale, Ariz.
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Denise Frank, Gates Healthcare, Middleton, MA
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Kimberly Hansen, Town & Country Compounding & Consultation Services, Ramsey, NJ
- Erin Michael, PCCA, Red Bluff, CA
- Michelle Moser, Makers Compounding Pharmacy, Mt. Vernon, Wash.
- Joseph Navarra, Town Total Compounding Center, Woodbury, NY
- Jennifer Petska, Alliance for Pharmacy Compounding, Minneapolis, Minn.
- Jonathan Pritchett, Revelation Pharma, Durham, NC
- Philip Smyth, Medisca, Lebanon, OH
- Tara Thompson, Revelation Pharma, Houston, Tex.
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A.J. Day receives APC's Malmberg Award | |
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A.J. Day, vice president of clinical services at PCCA, and an APC Board member, was named APC’s 2022 George and Lucy Malmberg Compounding Advocacy Champion during Compounders on Capitol Hill.
A.J. received the award for two prominent, very positive, and very productive accomplishments he achieved on behalf of the profession:
- His powerful testimony in support of glutathione at the FDA PCAC meeting in June 2022, where he testified under duress, having to speak rapidly and amid interruptions. Despite these challenges, his testimony was factual and compelling, and it voted in a positive vote for glutathione.
- Leading in assessing clinical research on compounded hormone therapy, which resulted in an important article in the journal Menopause in April of this year.
The award was presented by APC Board Chair Michael Blaire.
Congratulations, A.J., on this much deserved recognition!
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Some scenes from Capitol Hill visits | |
FDA grants GFI 256 enforcement delay | |
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In late July, APC led several pharmacy organizations in sending a joint letter asking FDA Center for Veterinary Medicine’s Dr. Steven Solomon for additional clarity regarding the agency’s animal compounding GFI.
Citing the inability of pharmacies and veterinarians to comply by the stated October 1, 2022, enforcement start date, the letter also requested an extension on the enforcement delay of GFI 256 until at least FY2024.
On Friday, September 9, APC received the agency's response, which acknowledged the joint request for clarification and—most importantly—granted us a six-month extension (April 2023) on the enforcement delay.
We’re grateful to CVM for its responsiveness to our request for an enforcement delay. We believe the delay is as essential to CVM as it is to compounding pharmacies and veterinarians as we all try to figure exactly what compliance with the new GFI looks like.
APC will continue to work with CVM to get the sort of clarity that can allow our members to create SOPs and bring their practices into compliance by the new April 2023 deadline.
Happy corgi image by Csilla Ozsvath from Pixabay
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FDA’s Bormel shares perspective: On Wednesday, FDA’s Director of Office of Compounding Quality and Compliance Gail Bormel joined APC’s Scott Brunner at CCH for an interview on a range of compounding regulatory issues. Attendees said it was a highlight of the conference. | |
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Compounding pharmacists pre-game for CCH. Pharmacy compounders (at right) turned out on Wednesday morning to support compounding champion Congressman Henry Cuellar at his APC/PCCA sponsored fundraiser.
PT shares our buzz. Pharmacy Times recently covered our news announcement regarding the physician-signed letter we submitted to FDA regarding compounded hormones.
Say yes to the...gown. The FDA Compounding Quality Center of Excellence recently announced it is offering a free, self-guided online course, Personnel Gowning in Sterile Drug Production. Learn more here.
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